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RU2010147000A - PHARMACEUTICAL COMPOSITION FOR ORAL USE - Google Patents

PHARMACEUTICAL COMPOSITION FOR ORAL USE Download PDF

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Publication number
RU2010147000A
RU2010147000A RU2010147000/15A RU2010147000A RU2010147000A RU 2010147000 A RU2010147000 A RU 2010147000A RU 2010147000/15 A RU2010147000/15 A RU 2010147000/15A RU 2010147000 A RU2010147000 A RU 2010147000A RU 2010147000 A RU2010147000 A RU 2010147000A
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RU
Russia
Prior art keywords
composition
mannitol
receptor agonist
octylphenyl
propan
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RU2010147000/15A
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Russian (ru)
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RU2475237C2 (en
Inventor
Томоюки ООМУРА (JP)
Томоюки ООМУРА
Мадхусудхан ПУДИПЕДДИ (US)
Мадхусудхан ПУДИПЕДДИ
Алан Эдуард РОЙС (US)
Алан Эдуард РОЙС
Коллин РЮГГЕР (US)
Коллин РЮГГЕР
Масаки САСАКИ (JP)
Масаки САСАКИ
Токухиро ТАМУРА (JP)
Токухиро ТАМУРА
Original Assignee
Новартис АГ (CH)
Новартис Аг
Митсубиши Танабе Фарма Корпорейшн (Jp)
Митсубиши Танабе Фарма Корпорейшн
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Application filed by Новартис АГ (CH), Новартис Аг, Митсубиши Танабе Фарма Корпорейшн (Jp), Митсубиши Танабе Фарма Корпорейшн filed Critical Новартис АГ (CH)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/145—Amines having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2)
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P37/02—Immunomodulators
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P41/00—Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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  • Health & Medical Sciences (AREA)
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  • Chemical & Material Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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Abstract

1. Фармацевтическая композиция, пригодная для перорального введения, которая содержит: ! (а) агонист рецептора S1P; и ! (б) маннит, ! причем эта композиция представляет собой твердую дозированную форму, маннит приготавливают из высушенной распылением композиции или обладает большой площадью специфической поверхности, а агонист рецептора S1P выбирают из 2-амино-2-[2-(4-октилфенил)этил]пропан-1,3-диола (FTY720), его фармацевтически приемлемой соли и РТY720-фосфата. ! 2. Композиция по п.1, в которой агонист рецептора S1P представляет собой 2-амино-2-[2-(4-октилфенил)этил]пропан-1,3-диол или его фармацевтически приемлемые соли. ! 3. Композиция по п.1, в которой агонист рецептора S1P представляет собой гидрохлорид 2-амино-2-[2-(4-октилфенил)этил]пропан-1,3-диола. ! 4. Композиция по любому из предшествующих пунктов, в которой маннит приготавливают из высушенной распылением композиции. ! 5. Композиция п.1 или 2, в которой маннит имеет средний размер частиц от 100 до 300 мкм или от 150 до 250 мкм. ! 6. Композиция п.1 или 2, в которой маннит имеет насыпную плотность от 0,4 до 0,6 г/мл или от 0,45 до 0,55 г/мл. ! 7. Композиция п.1 или 2, в которой маннит имеет удельную поверхность одной частицы от 1 до 7 м2/г. ! 8. Композиция п.1 или 2, в которой композиция дополнительно включает маннит, инозит, ксилит или лактит, например дополнительно включает ксилит. ! 9. Композиция п.1 или 2, в которой агонист рецептора S1P является измельченным и/или является предварительно просеянным. ! 10. Композиция п.1 или 2, дополнительно содержащая замасливатель. ! 11. Композиция по п.10, содержащая от 0,01 до 20 мас.% агониста рецептора S1P. ! 12. Композиция п.1 или 2, содержащая от 90 до 99,5 мас.% маннита. ! 13. Композиция п.1 или 2, где ко 1. A pharmaceutical composition suitable for oral administration that contains:! (a) an S1P receptor agonist; and! (b) mannitol! moreover, this composition is a solid dosage form, mannitol is prepared from a spray-dried composition or has a large specific surface area, and the S1P receptor agonist is selected from 2-amino-2- [2- (4-octylphenyl) ethyl] propan-1,3- diol (FTY720), a pharmaceutically acceptable salt thereof and PTY720 phosphate. ! 2. The composition according to claim 1, wherein the S1P receptor agonist is 2-amino-2- [2- (4-octylphenyl) ethyl] propan-1,3-diol or a pharmaceutically acceptable salt thereof. ! 3. The composition according to claim 1, wherein the S1P receptor agonist is 2-amino-2- [2- (4-octylphenyl) ethyl] propan-1,3-diol hydrochloride. ! 4. The composition according to any one of the preceding paragraphs, in which mannitol is prepared from a spray dried composition. ! 5. The composition of claim 1 or 2, in which mannitol has an average particle size of from 100 to 300 microns or from 150 to 250 microns. ! 6. The composition of claim 1 or 2, in which mannitol has a bulk density of from 0.4 to 0.6 g / ml or from 0.45 to 0.55 g / ml. ! 7. The composition of claim 1 or 2, in which mannitol has a specific surface area of one particle from 1 to 7 m2 / g ! 8. The composition of claim 1 or 2, in which the composition further comprises mannitol, inositol, xylitol or lactitol, for example further comprises xylitol. ! 9. The composition of claim 1 or 2, wherein the S1P receptor agonist is ground and / or pre-screened. ! 10. The composition of claim 1 or 2, additionally containing a sizing. ! 11. The composition of claim 10, containing from 0.01 to 20 wt.% S1P receptor agonist. ! 12. The composition of claim 1 or 2, containing from 90 to 99.5 wt.% Mannitol. ! 13. The composition of claim 1 or 2, where

Claims (15)

1. Фармацевтическая композиция, пригодная для перорального введения, которая содержит:1. A pharmaceutical composition suitable for oral administration, which contains: (а) агонист рецептора S1P; и(a) an S1P receptor agonist; and (б) маннит,(b) mannitol, причем эта композиция представляет собой твердую дозированную форму, маннит приготавливают из высушенной распылением композиции или обладает большой площадью специфической поверхности, а агонист рецептора S1P выбирают из 2-амино-2-[2-(4-октилфенил)этил]пропан-1,3-диола (FTY720), его фармацевтически приемлемой соли и РТY720-фосфата.moreover, this composition is a solid dosage form, mannitol is prepared from a spray-dried composition or has a large specific surface area, and the S1P receptor agonist is selected from 2-amino-2- [2- (4-octylphenyl) ethyl] propan-1,3- diol (FTY720), a pharmaceutically acceptable salt thereof and PTY720 phosphate. 2. Композиция по п.1, в которой агонист рецептора S1P представляет собой 2-амино-2-[2-(4-октилфенил)этил]пропан-1,3-диол или его фармацевтически приемлемые соли.2. The composition according to claim 1, wherein the S1P receptor agonist is 2-amino-2- [2- (4-octylphenyl) ethyl] propan-1,3-diol or a pharmaceutically acceptable salt thereof. 3. Композиция по п.1, в которой агонист рецептора S1P представляет собой гидрохлорид 2-амино-2-[2-(4-октилфенил)этил]пропан-1,3-диола.3. The composition according to claim 1, wherein the S1P receptor agonist is 2-amino-2- [2- (4-octylphenyl) ethyl] propan-1,3-diol hydrochloride. 4. Композиция по любому из предшествующих пунктов, в которой маннит приготавливают из высушенной распылением композиции.4. The composition according to any one of the preceding paragraphs, in which mannitol is prepared from a spray dried composition. 5. Композиция п.1 или 2, в которой маннит имеет средний размер частиц от 100 до 300 мкм или от 150 до 250 мкм.5. The composition of claim 1 or 2, in which mannitol has an average particle size of from 100 to 300 microns or from 150 to 250 microns. 6. Композиция п.1 или 2, в которой маннит имеет насыпную плотность от 0,4 до 0,6 г/мл или от 0,45 до 0,55 г/мл.6. The composition of claim 1 or 2, in which mannitol has a bulk density of from 0.4 to 0.6 g / ml or from 0.45 to 0.55 g / ml. 7. Композиция п.1 или 2, в которой маннит имеет удельную поверхность одной частицы от 1 до 7 м2/г.7. The composition of claim 1 or 2, in which mannitol has a specific surface area of one particle from 1 to 7 m 2 / g 8. Композиция п.1 или 2, в которой композиция дополнительно включает маннит, инозит, ксилит или лактит, например дополнительно включает ксилит.8. The composition of claim 1 or 2, in which the composition further comprises mannitol, inositol, xylitol or lactitol, for example further comprises xylitol. 9. Композиция п.1 или 2, в которой агонист рецептора S1P является измельченным и/или является предварительно просеянным.9. The composition of claim 1 or 2, wherein the S1P receptor agonist is ground and / or pre-screened. 10. Композиция п.1 или 2, дополнительно содержащая замасливатель.10. The composition of claim 1 or 2, additionally containing a sizing. 11. Композиция по п.10, содержащая от 0,01 до 20 мас.% агониста рецептора S1P.11. The composition of claim 10, containing from 0.01 to 20 wt.% S1P receptor agonist. 12. Композиция п.1 или 2, содержащая от 90 до 99,5 мас.% маннита.12. The composition of claim 1 or 2, containing from 90 to 99.5 wt.% Mannitol. 13. Композиция п.1 или 2, где композиция представляет собой единичную дозированную форму и содержит 0,5 до 10 мг агониста рецептора S1P.13. The composition of claim 1 or 2, where the composition is a unit dosage form and contains 0.5 to 10 mg of an S1P receptor agonist. 14. Композиция п.1 или 2, используемая в способе лечения и предупреждения отторжения трансплантата органа или ткани, или лечения аутоиммунного заболевания или воспалительных состояний, вирусного миокардита или вирусных заболеваний, связанных с вирусным миокардитом, или рассеянного склероза.14. The composition of claim 1 or 2, used in a method of treating and preventing organ or tissue transplant rejection, or treating an autoimmune disease or inflammatory conditions, viral myocarditis or viral diseases associated with viral myocarditis, or multiple sclerosis. 15. Композиция по п.14, используемая в способе лечения рассеянного склероза. 15. The composition of claim 14, used in a method for treating multiple sclerosis.
RU2010147000/15A 2003-04-08 2010-11-18 Oral pharmaceutical composition RU2475237C2 (en)

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US46121503P 2003-04-08 2003-04-08
US60/461,215 2003-04-08

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RU2009105403/15A Division RU2009105403A (en) 2003-04-08 2009-02-17 SOLID PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION (OPTIONS)

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RU2012148593/15A Division RU2012148593A (en) 2003-04-08 2012-11-15 PHARMACEUTICAL COMPOSITION FOR ORAL USE

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RU2475237C2 RU2475237C2 (en) 2013-02-20

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